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Agile Therapeutics Reports Second Quarter 2018 Financial Results
Cash Expected to
Second quarter 2018 and other recent corporate developments:
- Twirla® Update – As previously announced, Agile initiated formal dispute resolution with the U.S. Food and Drug Administration’s (
FDA) Office of Drug Evaluation III(ODE III) on June 6, 2018to appeal the complete response letter (CRL) the FDAissued in December 2017relating to the New Drug Application (NDA) for Twirla (AG200-15), the Company’s investigational non-daily, low-dose combination hormonal contraceptive patch. The Company initiated the formal dispute resolution process following an end-of-review meeting in April 2018in which the FDAprovided the Company with a more complete understanding of its assessment of the in vivo adhesion data for Twirla in the CRL. On July 24, 2018, the Company announced that FDA’s ODE III had affirmed the position of the Division of Bone, Reproductive and Urologic Products (DBRUP) and denied the Company’s appeal. The Company had appealed the decision communicated in the CRL that DBRUP’s concerns surrounding the in vivo adhesion properties of Twirla prevent its approval and cannot be addressed through the Company’s proposed patient compliance programs. The Company will escalate its appeal to the Office of New Drugs(OND) and, potentially, additional levels of FDAmanagement if necessary.
“We are focused on presenting and discussing our appeal with the
Second Quarter Financial Results
- Cash and cash equivalents: As of
June 30, 2018, Agile had $22.5 millionof cash and cash equivalents compared to $35.9 millionof cash and cash equivalents as of December 31, 2017. In June 2018, the Company announced a reduction in its workforce and reductions on other planned operating expenses as the Company pursues formal dispute resolution. As a result of these planned cost reductions, the Company believes its cash and cash equivalents as of June 30, 2018, will be sufficient to meet its operating requirements into the second quarter of 2019. The Company will require additional capital to fund operating needs for the remainder of the second quarter of 2019 and beyond, including among other items, the completion of its commercial plan for Twirla, which primarily includes validation of the commercial manufacturing process and the commercial launch of Twirla, if approved, and advancing the development of its other potential product candidates.
- Research and development (R&D) expenses: R&D expenses were
$2.4 millionfor the quarter ended June 30, 2018, compared to $3.8 millionfor the comparable period in 2017. The decrease in R&D expenses was primarily due to decreased clinical development expenses as the Company’s Phase 3 SECURE clinical trial for Twirla completed the close-out phase during 2017 as well as decreased regulatory expenses related to the preparation of the Company’s NDA resubmission and response to the FDA’s February 2013CRL in June 2017.
- General and administrative (G&A) expenses: G&A expenses were
$2.3 millionfor the quarter ended June 30, 2018, compared to $3.2 millionfor the comparable period in 2017. The decrease in G&A expenses was primarily due to the suspension of pre-commercialization activities as a result of the receipt of the CRL in December 2017.
- Net loss: Net loss was
$5.3 million, or $0.16per share for the quarter ended June 30, 2018, compared to a net loss of $7.4 million, or $0.26per share for the quarter ended June 30, 2017.
- Shares Outstanding: At
June 30, 2018, Agile had 34,377,329 shares of common stock outstanding.
About Twirla® (AG200-15)
Twirla (levonorgestrel/ethinyl estradiol transdermal system) or AG200-15 is an investigational low-dose, once-weekly contraceptive patch. AG200-15 is a combined hormonal contraceptive (CHC) patch that contains the active ingredients ethinyl estradiol (EE), a type of estrogen and levonorgestrel (LNG), a type of progestin. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch. Agile received a complete response letter (CRL) from the
Certain information contained in this press release includes "forward-looking statements" related to our regulatory submissions and projected cash position. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates," "estimates," "expects," "plans," "intends," "may," "could," “might," “likely,” "will," "should" or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties including statements regarding the fact that our existing cash and cash equivalents likely will not be sufficient to fund our current and planned operations beyond the second quarter of 2019, which raises substantial doubt about our ability to continue as a going concern, and which, in turn, may create negative reactions to the price of our common stock making it more difficult to obtain financing in the future, our ability to succeed in formal dispute resolution with the
Contact: Investor Relations -- 609-683-1880
|Agile Therapeutics, Inc.|
|Condensed Balance Sheets|
|Cash and cash equivalents||$||22,465||$||35,952|
|Total current assets||22,665||36,714|
|Property and equipment, net||13,924||13,863|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||2,829||$||3,636|
|Loan payable, current portion||7,525||10,607|
|Additional paid‑in capital||260,199||258,092|
|Total stockholders’ equity||26,253||36,323|
|Total liabilities and stockholders’ equity||$||36,607||$||50,595|
|Agile Therapeutics, Inc.|
|Condensed Statements of Operations|
|(in thousands, except share and per share amounts)|
|Three Months Ended
|Six Months Ended
|Research and development||$||2,413||$||3,798||$||6,372||$||8,519|
|General and administrative||2,318||3,198||5,404||5,603|
|Total operating expenses||5,147||6,996||12,192||14,122|
|Loss from operations||(5,147||)||(6,996||)||(12,192||)||(14,122||)|
|Other income (expense)|
|Change in fair value of warrants||22||(7||)||29||102|
|Loss before benefit from income taxes||(5,344||)||(7,446||)||(12,654||)||(14,961||)|
|Benefit from income taxes||—||—||477||—|
|Net loss per share - basic and diluted||$||(0.16||)||$||(0.26||)||$||(0.36||)||$||(0.52||)|
|Weighted‑average shares outstanding –basic and diluted||34,277,601||28,802,112||34,253,515||28,785,827|
Source: Agile Therapeutics, Inc.